A reader of this blog recently sent me the following message: “Looks like this group followed you recent post about how to perform a CAM RCT!” A link directed me to a new trial of ear-acupressure. Today is ‘national acupuncture and oriental medicine day’ in the US, a good occasion perhaps to have a critical look at it.
The aim of this study was to assess the effectiveness of ear acupressure and massage vs. control in the improvement of pain, anxiety and depression in persons diagnosed with dementia.
For this purpose, the researchers recruited a total of 120 elderly dementia patients institutionalized in residential homes. The participants were randomly allocated, to three groups:
- Control group – they continued with their routine activities;
- Ear acupressure intervention group – they received ear acupressure treatment (pressure was applied to acupressure points on the ear);
- Massage therapy intervention group – they received relaxing massage therapy.
Pain, anxiety and depression were assessed with the Doloplus2, Cornell and Campbell scales. The study was carried out during 5 months; three months of experimental treatment and two months with no treatment. The assessments were done at baseline, each month during the treatment and at one and two months of follow-up.
A total of 111 participants completed the study. The ear acupressure intervention group showed better improvements than the two other groups in relation to pain and depression during the treatment period and at one month of follow-up. The best improvement in pain was achieved in the last (3rd) month of ear acupressure treatment. The best results regarding anxiety were also observed in the last month of treatment.
The authors concluded that ear acupressure and massage therapy showed better results than the control group in relation to pain, anxiety and depression. However, ear acupressure achieved more improvements.
The question is: IS THIS A RIGOROUS TRIAL?
My answer would be NO.
Now I better explain why, don’t I?
If we look at them critically, the results of this trial might merely prove that spending some time with a patient, being nice to her, administering a treatment that involves time and touch, etc. yields positive changes in subjective experiences of pain, anxiety and depression. Thus the results of this study might have nothing to do with the therapies per se.
And why would acupressure be more successful than massage therapy? Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc. Features like that have the potential to maximise the placebo-response. Therefore it is conceivable that they have contributed to the superiority of acupressure over massage.
What I am saying is that the results of this trial can be interpreted in not just one but several ways. The main reason for that is the fact that the control group were not given an acceptable placebo, one that was indistinguishable from the real treatment. Patients were fully aware of what type of intervention they were getting. Therefore their expectations, possibly heightened by the therapists, determined the outcomes. Consequently there were factors at work which were totally beyond the control of the researchers and a clear causal link between the therapy and the outcome cannot be established.
An RCT that is aimed to test the effectiveness of a therapy but fails to establish such a causal link beyond reasonable doubt cannot be characterised as a rigorous study, I am afraid.
Sorry! Did I spoil your ‘national acupuncture and oriental medicine day’?
11 Responses to A decent trial of ear-acupressure? (Don’t let this spoil your National Acupuncture and Oriental Medicine Day!)
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“Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc.”
Do you know how many of the 111 this applies to, or is this just pure speculation?
Since acupuncture works by placebo responses to expectations (and not by stimulating meridians, chi or vital forces – none of which have ever been demonstrated to exist) the more theatrical the placebo the greater the effect.
That is what this study prooves.
Not all placebos are the same.
So how many of the 111 consider acupuncture ‘more theatrical’ than massage? How many find it exotic, how many grew up with it, how many understand the science behind it, how many think its magic, etc etc. What are their experiences and views on massage? Or are you speculating like Edzard?
111 is total number of participant, not the number of participant receiving magical intervention. Then, obviously a significant amount of them liked it maybe like 20 ? I cannot see because of the paywall.
Anyway this study look poor : 120 patient with ‘dementia’. There is a lot of different dementia. For exemple, it is know that parkison people are more likely to be affected by placebo effect, so the response will be artificially stronger. A small sample like this cannot get rid of this kind of repartition bias.
And of course the ‘control group’ is bad like Edzard say.
And more, the simple science behind this is null. It’s like looking on “how santa can deliver his present across the world”, implicitly admitting that santa exist. Those trials are a waste of time and money.
“111 is total number of participant” – yup.
“participant receiving magical intervention” – no magic, just massage and acupressure.
“And more, the simple science behind this is null.” In which case, the speculation “Massage therapy is an ‘old hat’ for many patients; by contrast, acupressure is exotic and relates to mystical life forces etc.” is nonsense for the sake of drama.
if you say so.
jm, read the complete sentence, don’t take it bit by bit because it make no sense at all. Now I understand better why you miss most of what is usually written here.
And you are still dodging the point.
@Edzard – prove otherwise. Were there questions on their health history/intake/whatever about the patients views on massage and acupressure? And if so, what were the numbers?
@Quark – so tell me what point I’m dodging.
The title of this post mentions ear acupuncture, and yet the study looks at ear acupressure, a different therapy. Seems pretty sloppy for a blog that espouses scientific rigor.
good point!
I have changed it